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PHARMIWEB SOAPBOX: Marketing Regulations – Is Onli

Posted on: 27 Mar 03
PHARMIWEB SOAPBOX: Marketing Regulations – Is Onli

Summary

According to all pharmaceutical regulatory authorities of note, the regulations that apply to offline sales and marketing activity in the industry should also apply to all such activity in the online
Colin Williams, PharmiWeb’s e-Marketing Manager, discusses the much-debated topic of online marketing regulations.

Fact

According to all pharmaceutical regulatory authorities of note (for example, the ABPI, BMA and MCA here in the UK), the regulations that apply to offline sales and marketing activity in the industry should also apply to all such activity in the online world. Here at PharmiWeb, we agree wholeheartedly with this view and go to great lengths to ensure that any online projects we undertake for pharmaceutical clients meet with these regulations. However (and there has to be a however does there not?), there still remain some areas of online marketing which require specific, clear and unambiguous regulatory guidelines.

It is amazing to think that in 2003 we are still talking about ‘pioneering cases’ in online pharmaceutical sales and marketing where new regulatory boundaries are being tested…tested in many cases because of this lack of clarity that still prevails. E-Detailing (a means of promoting products to customers online and therefore mimicking the interaction between the pharmaceutical sales rep and healthcare professional in the offline world) is an area where this author has significant expertise, and one that has come under the regulatory spotlight recently, therefore making an ideal case study for this discussion.

The PMCPA (The Prescription Medicines Code of Practice Authority) is the part of the ABPI (The Association of the British Pharmaceutical Industry) that operates its Code of Practice for the pharmaceutical industry independently of the ABPI itself, a confusing statement alone to the uninformed reader, and one that I come back to later. In November, an ABPI alert was released relating to two breaches in the Code of Practice concerning e-Detailing and Market Research1.

e-Detailing and Market Research

An anonymous general practitioner complained to the ABPI about an e-detail for a key product from a leading pharmaceutical company on an Internet website owned by a third party service provider. The ABPI panel considering the complaint decided in effect that the site was providing product promotion disguised as market research and that this was done in a misleading manner. Breaches of clauses 9.1, 10.1 and 18.1 were ruled. A further complaint regarding the security of the website in terms of providing healthcare professional-only access was upheld as there is currently ‘no advice in the Code on this point’. However, the panel did consider that ‘the arrangements for access to the website were on the limits of acceptability with regards to security’.

It was different in my day…

As an ex-industry market researcher, I used to think nothing of recruiting a number of doctors, booking a meeting room for a couple of days, taking one of our sales reps along, getting them to give a sales presentation to each invited doctor at allotted times throughout the day(s), followed by myself interviewing the doctor to gain their opinions of the sales call and materials presented…this is still the norm in the ‘real world’ and it is still called ‘Detail Hall Tests’. The invited doctors get paid for their time (£50+ I believe is today’s going rate for GPs for example), and they know that while the main purpose of the exercise is market research, they will be exposed to material of a promotional nature.

Going back to my original point, the regulations for this particular offline activity are specific and therefore are able to be clearly interpreted by all concerned…can you see my thrust?

PharmiWeb’s approach

While we wait for the clarity we need in this area, PharmiWeb have adopted a pragmatic approach to ensure that we - and our clients - do not fall foul of the regulations as they stand (or any interpretation thereof). Current e-detailing projects that we are running include incentives, promotional material, and education, and require security to access the website. For us, clarity and security are very much at the top of the e-detailing agenda. For example:

Clearly distinguish between promotional and educational material, and ensure that any incentives offered for non-promotional purposes are not dependant on the viewing of promotional material.

In terms of security, Detail-Direct.com (our e-Detailing portal) and the e-details that sit within it are only accessible via the PVS (see: www.verifies.co.uk ) verification server that includes a unique user name and password for every UK healthcare professional, and can also validate against international registrations from across the globe.

Apart from constantly keeping up to date ourselves, we also draw knowledge from an expert panel to stay abreast of all national and international regulations that affect what we and our clients do.

And Finallly…PMCPA & ABPI

…One is part of the other yet entirely autonomous of its mother company. The mother company promotes the practices of the pharmaceutical industry in the UK, yet the lack of clarity and understanding of the industry in the current ‘Code of Practice’ has, and still does, serve to hinder many morally legitimate sales and marketing activities before they are able to get off the ground and prove their worth to the market as a whole and healthcare professionals & patients in particular…this author feels its high time such regulatory bodies were reviewed to ensure they understand and meet the needs of all stakeholders involved in healthcare and pharmaceuticals. I believe that now is an ideal time for the industry, regulatory bodies, service providers (such as PharmiWeb) and other stakeholders, to work together to create a clear framework for online product promotion.

Comments always welcome. Please feel free to email me at: colin@pharmiweb.com or call me on +44 (0)1344 667430.

1A copy of the findings in full can be found in the Code of Practice Review, November 2002 obtainable in hard copy format only from: Prescription Medicines Code of Practice Authority, 12 Whitehall, London, SW1A 2DY. Tel: +44 (0)20 7930 9677. Fax: +44 (0)20 7930 4554

Colin Williams

Last updated on: 27/08/2010 11:40:18

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